drugset / Trial / NCT07344558

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis

NCT07344558

Phase 1 Recruiting 24 enrolled Mannkind Corporation
RandomizedSequentialDouble-blindTreatment

Summary

MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.

Timeline

Start
2025-12-22
Primary completion
2026-06-15
Completion
2026-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Nintedanib Small molecule Inhaled